Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Amendment
In the amendment dated 03/16/2026, the following occurred: Claims 1-25 are canceled; and claims 26-44 are new.
Claim 44 is withdrawn from consideration in accordance with the election by original presentation herein.
Claims 26-43 are pending and have been examined.
Priority
This application claims priority to U.S. Provisional Patent Application No. 63/516,039 filed 07/27/2023.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. §121:
Group I claims (26, 43 and their dependents) are drawn to a method for producing aggregate data for the effectiveness of a treatment on an individual, classified in G16H 10/20.
Group II claim (44) is drawn to a method for building an aggregated evaluation database from a plurality of blinded, self-administered experiments, classified in G16H 10/20.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination (I) and sub-combination (II). Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the sub-combination as claimed for patentability, and (2) the sub-combination has utility by itself or in other combinations (see MPEP § 806.05 (c)). In the instant case, the combination (I) as claimed does not require the particulars of the sub-combination (II) as claimed because: receiving, at an electronic repository, evaluation data from a plurality of experiments, as drafted, is not required. The sub-combination (II) has separate utility such as building an aggregated evaluation database for a plurality of blinded, self-administered experiments.
The Examiner has required restriction between combination and sub-combination inventions. Where Applicant elects a sub-combination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable sub-combination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims in the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification.
The inventions have acquired a separate status in the art due to their recognized divergent subject matter.
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The prior art applicable to one invention would not likely be applicable to another invention.
The inventions are likely to raise different non-prior art issues under 35 U.S.C. §101 and/or 35 U.S.C. §112(a) (i.e., concerning the written description requirement).
In the present case, the inventions of Group I and Group II diverge such that the prior art applicable to one invention would not likely be applicable to another invention; and the inventions likely raise different non-prior art issues.
Newly submitted claim 44 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 44 added in response to the Office action mailed 12/23/2025 is directed to a method for building an aggregated evaluation database from a plurality of blinded, self-administered experiments. The invention originally claimed is directed to a method for executing a clinical trial on an individual or a method for facilitating a self-administered clinical trial on the individual. The invention originally claimed is independent and distinct from what is done with the data obtained by executing a plurality of these clinical trials or experiments.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 44 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder (e.g., “module”, “interface”) that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. See e.g., MPEP 2181(V). Such claim limitation(s) is/are:
In claim 43, “a blinding module configured to associate blinding-compliant apparatus containing coded packaging of the treatment material and a control material with a protocol record…”
In claim 43, “a recording module configured to receive responses of the individual relating to the one or more outcome measures and exclusion designations…”
In claim 43, “a filtering module configured to classify outcome data… by excluding from analysis, down-weighting, or designating as impaired outcome data associated with a recorded unblinding event…”
In claim 43, “a calculating module configured to calculate via a statistical processor an individual effectiveness estimate…”
In claim 43, “an aggregation module configured to automatically aggregate in the electronic repository evaluation data from a plurality of evaluations…” (e.g., applies a compliance rule set).
In claim 43, “an iteration module configured to automatically use the aggregated evaluation data to iteratively reconfigure evaluation protocols or provide updated information…” (e.g., updating one or more statistical baselines, generating anonymized effectiveness reports).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The Specification describes the corresponding structure, material or acts as follows:
The “blinding module” corresponds to a computing device (see specification at para. 0004). Note: The BRI in light of the specification for the corresponding structure and equivalents thereof is understood to be any computer and functionality programmed to associate blinding-compliant coded packaging data with a protocol record.
The “recording module” corresponds to a computing device (see specification at para. 0004). Note: The BRI in light of the specification for the corresponding structure and equivalents thereof is understood to be any computer and functionality programmed to receive responses of the individual.
The “filtering module” corresponds to a computing device (see specification at para. 0004). Note: The BRI in light of the specification for the corresponding structure and equivalents thereof is understood to be any computer and functionality programmed to classify outcome data by filtering out outcome data associated with a recorded unblinding event.
The “calculating module” corresponds to a computing device (see specification at para. 0016, 0069 and Fig. 1C). Specification at para. 0016 states that the “system may further include a statistical analysis module configured to calculate results of the trial based on outcome measures”.
The “aggregation module” corresponds to a computing device (see specification at para. 0004). Note: The BRI in light of the specification for the corresponding structure and equivalents thereof is understood to be any computer and functionality programmed to aggregate evaluation data from a plurality of evaluations by applying a compliance rule set.
The “iteration module” corresponds to a computing device (see specification at para. 0004). Note: The BRI in light of the specification for the corresponding structure and equivalents thereof is understood to be any computer and functionality programmed to use aggregated evaluation data to iteratively reconfigure evaluation protocols or provide updated information (e.g., update one or more statistical baselines or generate anonymized effectiveness reports).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
This application includes one or more claim limitations that use the word “means” or “step” (or a generic placeholder, e.g., “module”) but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
In claim 43, “a protocol generation module configured to receive a set of evaluation parameters via an electronic interface…” (emphasis added to the generic placeholder and its structure, material, or acts).
In claim 43, “a prompting module configured to prompt the individual through conducting an evaluation of the treatment by transmitting randomized, sequenced dosing and outcome-response instructions via an electronic device…” (emphasis added to the generic placeholder and its structure, material, or acts). See also specification at para. 0069.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 26-43 are rejected for lacking written description.
Claims 26, 35, 41 and 43 are rejected under 35 U.S.C. §112(a) for lacking written description for the recitation of “a calculating module configured to calculate via a statistical processor an individual effectiveness estimate…” (claim 43 being representative). This is a new matter rejection. New matter added to the claims shall be rejected under 112a. MPEP § 2163.06(I).
The Applicant’s original claims along with the Specification at para. 0016 (“[t]he system may further include a statistical analysis module configured to calculate results of the trial based on outcome measures recorded by the individual, and to communicate the results to the individual”), para. 0069 (“[m]easurement of some of these items may be facilitated by devices such as smartwatches”), and Fig. 1C (“System prompts user for dosing”, “System performs calculation of effect size”) fail to provide support for “a statistical processor” as the support pertains to a “statistical analysis module” of the system / device (the recited “electronic device”), not a “statistical processor”. The specification discloses the system / device but is silent as to a processor subsystem. The rejection of independent claim 26 also applies to its dependent claims 27-42.
Claims 26 and 43 also are rejected for lacking written description for the recitation of “an electronic repository”. This is also a new matter rejection. The Applicant’s original claims along with the Specification fail to provide support for “an electronic repository” or any term that would be construed as interchangeable. For example, the Specification is silent regarding the terms of “repository”, “repositories”, “storage”, and “memory”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 26-43 are rejected under 35 U.S.C. §101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 26 and 43 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 (YES)
Claims 26 and 43 recite a process and system for producing aggregate data for the effectiveness of a treatment on an individual, which are within a statutory category.
Step 2A1 (YES)
The limitations of selecting and receiving a set of evaluation parameters…, the evaluation parameters including a treatment material and one or more outcome measures indicative of the effectiveness of the treatment; associating… coded packaging of the treatment material and a control material with a stored protocol record; providing the individual with… coded packaging of the treatment material and the control material, wherein the coded packaging bears identifiers associated with a material assignment stored… without disclosing that assignment to the individual; automatically storing a protocol record associated with the blinding-compliant apparatus…; automatically prompting the individual through conducting an evaluation of the treatment by providing randomized, sequenced dosing and outcome-response instructions… in accordance with a randomization schedule associated with the coded packaging, wherein the randomization schedule and material assignments remain blinding-compliant by being maintained… without disclosure to the individual throughout the evaluation; recording responses of the individual relating to the one or more outcome measures…, and receiving any exclusion designations generated by the individual…, each designation identifying a protocol deviation or a confounding factor and comprising one or more outcome measures or doses for filtering from analysis; storing the outcome measures as outcome data; for any unblinding event, recording the unblinding event…, and excluding from analysis, or designating as impaired, any outcome data that is associated with the recorded unblinding event; automatically calculating… an individual effectiveness estimate from outcome data not excluded from analysis by selectively excluding or down-weighting outcome data designated as impaired or flagged by the exclusion designations; automatically aggregating… evaluation data from a plurality of evaluations, wherein the evaluation data includes blinding-compliant outcome data and calculated effectiveness estimates, wherein the aggregation process applies a compliance rule set to reject or weight the aggregated evaluation data based on protocol information including one or more of randomization identifiers, package identifiers, treatment materials, outcome measures, exclusion designation history, and protocol record states; and automatically using the aggregated evaluation data to iteratively reconfigure evaluation protocols or provide updated information for future participants by (1) updating one or more statistical baselines derived from the aggregated evaluation data, or (2) generating anonymized effectiveness reports for future participants that present aggregated evaluation data from the repository, as drafted (claim 26 being representative), is a process that under the broadest reasonable interpretation (BRI) covers a method of organizing human activity (i.e., managing personal behavior or relationships or interactions between people including following rules or instructions) but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person to follow, with or without the aid of a computer, to produce aggregate data for the effectiveness of a treatment on an individual, which includes monitoring the compliance of a patient following a blinded treatment protocol and receiving patient-reported outcomes (see Specification para. 0077 describing self-administered trials, biostatistical analysis service, trial interpretation as a human activity. See also para. 0018, 0019, 0037 describing use of a trial service provider as a human activity. See also para. 0048-0051 describing use of a blinded N-of-1 service as a human activity) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “selecting and receiving… associating… providing…automatically storing… automatically prompting… recording… receiving… storing… recording… excluding… automatically calculating… automatically aggregating… automatically using… to iteratively reconfigure… or provide…” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a system implemented by a data processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2 (NO)
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of an electronic device having various modules, a statistical processor, an electronic interface, and an electronic repository that implement the identified abstract idea. The additional elements aforementioned are not described by the applicant and are recited at a high-level of generality (i.e., a generic computer or computer component performing a generic computer or computer component function that facilitates the identified abstract idea) such that these amount no more than mere instructions to apply the exception using a generic computer component (see Specification at para. 0004, 0016, 0027, 0069-0070). See MPEP § 2106.04(d)(I). Accordingly, alone or in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional element of a blinding-compliant apparatus containing coded packaging of the treatment material and a control material used to perform the identified abstract idea. The additional element is not described by the applicant and is recited at a high level of generality, such that the additional element amounts no more than merely reciting the words “apply it” (or an equivalent) with the judicial exception (e.g., conduct an evaluation with the provided instructions and materials), which is insufficient to provide a practical application. See MPEP § 2106.04(d)(I). The Examiner notes that mere physicality or tangibility of this additional element is not a relevant consideration. Accordingly, even in combination, the additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional element of an automated monitoring device that collects, transmits or outputs data. The additional element is recited at a high-level of generality (i.e., as a general means of collecting, transmitting or outputting data) and amounts to a location from which data is received or to which data is transmitted or outputted, each of which represents an extra-solution activity. See MPEP § 2106.04(d)(I). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claims are directed to an abstract idea.
Alternately, the additional element of the automated monitoring device could be considered generally linking since the exclusion designations may be generated (i.e., collected) and transmitted by the individual alone and optionally generated and transmitted using the automated monitoring device. Under practical application, the additional element is merely generally linking the use of the abstract idea to a particular technological environment or field of use. MPEP § 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B (NO)
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of an electronic device having various modules, a statistical processor, an electronic interface, and an electronic repository to perform the method amounts no more than mere instructions to apply the exception using a generic computer or generic computer component. Mere instructions to apply an exception using generic computer(s) and/or generic computer component(s) (i.e., alone or even in combination) cannot provide an inventive concept (“significantly more”). See MPEP § 2106.05(f).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a blinding-compliant apparatus containing coded packaging of the treatment material and a control material used to perform the method amounts no more than merely reciting the words “apply it” (or an equivalent) with the judicial exception, which is insufficient to provide a practical application. See MPEP §§ 2106.05(a) and (f). Merely reciting the words “apply it” (or an equivalent) with the judicial exception cannot provide an inventive concept (“significantly more”).
Also discussed above with respect to integration of the abstract idea into a practical application, the additional element of an automated monitoring device (i.e., a device that collects, transmits or outputs data) is considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2016.05(d)(II) indicates that receiving, transmitting and outputting data over a network, e.g. using the Internet to gather data, has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). See also MPEP 2106.05(g) (citing CyberSource, Mayo and OIP Techs.) Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such, the claims are not patent eligible.
As discussed above with respect to integration of the abstract idea into a practical application, in the alternative, the additional element of the automated monitoring device could be considered generally linking the use of the abstract idea to a particular technological environment or field of use (since the exclusion designations may be generated and transmitted by the individual alone and optionally generated and transmitted using the automated monitoring device). This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP § 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more; as such, the claim is not patent eligible.
Dependent claims 27-42, when analyzed as a whole, are similarly rejected under 35 U.S.C. §101 because the additional limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. The claims, when considered alone or as an ordered combination, either (1) merely further define the abstract idea, (2) do not further limit the claim to a practical application, or (3) do not provide an inventive concept such that the claims are subject matter eligible.
Claim(s) 27-29, 31, 33-34, 36, 38-40 and 42 merely further describe(s) the abstract idea (e.g., calculating the individual effectiveness estimate, the anonymized effectiveness report, using the aggregated effectiveness data to reconfigure evaluation parameters or protocol options, providing the individual with incentives or rewards, the treatment material is a dietary supplement, the control material is a placebo, offering the individual the option to continue using one or more of the treatment or control material following the evaluation with the material assignment of the coded packaging remaining concealed from the individual, dynamically updating one or more protocol details during the evaluation of the individual based on previous data from the individual, assigning unequal durations to treatment and control periods within the evaluation, the one or more outcome measures). See analysis, supra.
Claims 30, 35 and 37 merely further describe the additional element of the generic electronic device that implements the abstract idea (e.g., to deliver instructions via a dedicated smartphone application, to terminate the evaluation prior to a scheduled completion date based on a choice to terminate by the individual, to allow the individual to define one or more custom outcome measures) at a high-level of generality. See analysis, supra.
Claim 32 merely further describes the additional element of the electronic monitoring device as receiving, transmitting or outputting data at a high level of generality. See analysis, supra.
Claim 36 merely further describes the additional element of the generic electronic interface that implements the abstract idea (e.g., to customize the set of evaluation parameters, to select from among predetermined options) at a high level of generality. See analysis, supra.
Claim 41 merely further describes the additional element of the generic statistical processor that implements the abstract idea (e.g., incorporating one or more of onset time, washout time, and moving baseline data adjustments in calculations) at a high level of generality. See analysis, supra.
Response to Arguments
Claim interpretation
Regarding the interpretation of claims 1-25, the Applicant has canceled claims 1-25, rendering the claim interpretation moot for these claims. New claim interpretation is invoked by new claim(s).
Rejections under 35 U.S.C. §112
Regarding the rejection of claims 2-3, 12-13 and 17-19, the Applicant has cancelled the claims to obviate the previous issues of indefiniteness under 112(b). New claim(s) present new matter issues under 112(a).
Rejections under 35 U.S.C. §101
Regarding the rejection of Claims 1-25, the Applicant has cancelled claims 1-25, rendering the rejection of those claims moot. Regarding the new claims 26-43 elected by original presentation, the Examiner has considered the Applicant’s arguments but does not find them persuasive for at least the following reasons. Applicant argues:
A1. “Claim 26 recites real, tangible (not abstract) elements such as blinding compliant apparatus that contains coded packaging of treatment and control materials that, when administered in accordance with a randomization schedule associated with the coded packaging, automatically maintains blinding compliance without additional human intervention” (Remarks, pg. 14).
Re. argument A1: The Examiner respectfully submits that mere recitation of concrete, tangible components is insufficient to confer patent eligibility to an otherwise abstract idea. MPEP 2106(I). The additional element of a blinding-compliant apparatus containing coded packaging of the treatment material and a control material is not described by the applicant and is recited at a high level of generality, such that the additional element amounts no more than merely reciting the words “apply it” (or an equivalent) with the identified abstract idea (e.g., conduct an evaluation with the provided instructions and materials without disclosing the test material to the participant). Managing the behavior of participant(s) in single-blind studies is a human activity. See, e.g., Applicant’s disclosure at para. 0089. Also, the creation and assignment of a randomization schedule is something a human (e.g., a supplier, a coordinating facility member) can do as part of the instructions with or without computer implementation. See, e.g., Applicant’s disclosure at para. 0063.
The Examiner notes that the subject matter eligibility analysis does not characterize the claims as a “mental process”. Arguments related to mental processes will not be addressed because the Examiner has provided analysis related to the “certain methods of organizing human activity” sub-grouping of abstract ideas.
A2. “Applicant further submits that the claimed method is integrated to transform the recited steps into a real-world application in which the effectiveness estimates and outcome data remain blinding-compliant so that they can be aggregated into an electronic repository by applying a compliance rule set, the electronic repository containing other similar data, thereby allowing evaluation protocols to be iteratively reconfigured using the aggregated evaluation data” (remarks, pg. 15).
Re. argument A2: See response to argument A1. Additionally, the portion relied upon in argument is part of the abstract idea. While the abstract idea may be improved (e.g., an improved manner of record keeping to users), an improved abstract idea does not provide a technical improvement, such an improvement to the operation of the computer itself or an improvement to data storage itself. Even when considered in combination with the additional elements, these improvements are not technical improvements that would integrate the abstract idea into a practical application.
Regarding the rejection of Claims 27-43, the Applicant has not offered any or any additional arguments with respect to these claims other than to reiterate the argument(s) present for the claim(s) from which they depend or are analogous to. As such, the rejection of these claims is also respectfully maintained.
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claims 26 and 43 as follows (claim 26 being representative):
blinding-compliant apparatus coded packaging of the treatment material and the control material, wherein the coded packaging bears identifiers associated with a material assignment stored in an electronic repository,
automatically storing a protocol record associated with the blinding-compliant apparatus in an electronic repository,
automatically prompting the individual through conducting an evaluation of the treatment by providing randomized, sequenced dosing and outcome-response instructions via an electronic device in accordance with a randomization schedule associated with the coded packaging, wherein the randomization schedule and material assignments remain blinding-compliant by being maintained by the electronic device without disclosure to the individual throughout the evaluation,
each designation identifying a protocol deviation or a confounding factor and comprising one or more outcome measures or doses,
for any unblinding event, recording the unblinding event in the electronic repository, and excluding from analysis, or designating as impaired, any outcome data that is associated with the recorded unblinding event,
selectively excluding or down-weighting outcome data designated as impaired or flagged by the exclusion designations, and
automatically aggregating in the electronic repository evaluation data from a plurality of evaluations, wherein the evaluation data includes blinding-compliant outcome data and calculated effectiveness estimates, wherein the aggregation process applies a compliance rule set to reject or weight the aggregated evaluation data based on protocol information including one or more of randomization identifiers, package identifiers, treatment materials, outcome measures, exclusion designation history, and protocol record states.
The most remarkable prior art of record is as follows:
WO 2023/129672 A1 to Eetemadi et al. (“Eetemadi”) for teaching framework for constrained adaptive group testing.
US 6,242,463 B1 to Reitberg for teaching a method and kit for treating illnesses including administering drugs and placebos to each member of the pool in a random, double-blinded fashion (see Abstract).
WO 2019/055879 A2 to Heywood et al. (“Heywood”) for teaching a user interface prompting/soliciting health information from individuals, such as their treatments and patient-reported outcomes, on a customized time schedule (see para. 0055, 0163).
US 2019/0214116 A1 to Eberting for teaching digital health platform for chronic disease management, secure messaging, prescription management, and integrated e-commerce curation (see Abstract).
US 2011/0153358 A1 to Campo et al. (“Campo”) for teaching a protocol complexity analyzer (see Abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2023/0346718 A1 to D’Souza for teaching method of treating, ameliorating and/or preventing depression (para. 0196, 0224, 0230).
US 2023/0127401 A1 to Bekelman et al. for teaching machine learning systems using electronic health record data and patient-reported outcomes (para. 0055).
US 2022/0284994 A1 to Ellis et al. for teaching health monitoring system with configurable data collection and processing (see Abstract).
US 2004/0249664 A1 to Broverman et al. for teaching design assistance for clinical trial protocols (see Abstract).
US 2003/0125609 A1 to Becker for teaching method for reliable measurement in medical care and patient self-monitoring (see Abstract and all figures).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.M.W./ Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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